Conversion to Embeda With Rescue Trial

NCT01179191

Last updated date
Study Location
Adamsville Family Medicine
Adamsville, Alabama, 35005, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Disease, Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Be able to read, speak and understand English

- Have chronic moderate to severe pain for at least 3 months

- Require around the clock opioid medication for the relief of pain

- Have been taking a daily opioid for at least 30 days prior to starting the study

- Be able to be safely switched to a different pain medication

- Be practicing acceptable birth control methods for female patients of childbearing potential

- Be willing to participate in the study and able to comply with study procedures

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Be currently diagnosed with or participating in and/or seeking treatment for opioid
and/or alcohol abuse


- Be allergic or intolerant to morphine, morphine salts, naltrexone or other opioids


- Be currently taking tramadol and/or extended release morphine products


- Have respiratory depression


- Have acute or severe bronchial asthma or severe chronic obstructive pulmonary disease


- Have migraines as your main source of pain


- Have any form of bowel obstruction


- Be pregnant or breast feeding


- Have had 2 or more surgeries for low back pain


- Be planning a major surgery during the study


- Be staying in a hospital or nursing home


- Be planning to have steroid injections for your chronic pain during the study


- Have a life expectancy of less than 2 months

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

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[email protected]

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Chronic Disease, PainConversion to Embeda With Rescue Trial NCT01179191
  1. Adamsville, Alabama
  2. Birmingham, Alabama
  3. Huntsville, Alabama
  4. Huntsville, Alabama
  5. Mobile, Alabama
  6. Montgomery, Alabama
  7. Goodyear, Arizona
  8. Phoenix, Arizona
  9. Phoenix, Arizona
  10. Phoenix, Arizona
  11. Sierra Vista, Arizona
  12. Tempe, Arizona
  13. Tucson, Arizona
  14. Hot Springs, Arkansas
  15. Jonesboro, Arkansas
  16. Paragould, Arkansas
  17. Costa Mesa, California
  18. Foothill Ranch, California
  19. Inglewood, California
  20. La Mesa, California
  21. Laguna Hills, California
  22. Long Beach, California
  23. Los Angeles, California
  24. Los Gatos, California
  25. Newport Beach, California
  26. Paramount, California
  27. Pasadena, California
  28. Roseville, California
  29. Sacramento, California
  30. Sacramento, California
  31. San Marcos, California
  32. Santa Ana, California
  33. Santa Ana, California
  34. Upland, California
  35. Valley Village, California
  36. Aurora, Colorado
  37. Colorado Springs, Colorado
  38. Fort Collins, Colorado
  39. Manchester, Connecticut
  40. Milford, Connecticut
  41. Boynton Beach, Florida
  42. Clearwater, Florida
  43. Debary, Florida
  44. DeBary, Florida
  45. Dunnellon, Florida
  46. Hialeah, Florida
  47. Hialeah, Florida
  48. Kissimmee, Florida
  49. Lakeland, Florida
  50. Miami Beach, Florida
  51. Miami, Florida
  52. Miami, Florida
  53. North Miami Beach, Florida
  54. North Palm Beach, Florida
  55. Ocala, Florida
  56. Pinellas Park, Florida
  57. Pompano Beach, Florida
  58. Sarasota, Florida
  59. Tampa, Florida
  60. Wellington, Florida
  61. Atlanta, Georgia
  62. Columbus, Georgia
  63. Decatur, Georgia
  64. Stone Mountain, Georgia
  65. Suwanee, Georgia
  66. Tifton, Georgia
  67. Chicago, Illinois
  68. Creve Coeur, Illinois
  69. Peoria, Illinois
  70. Indianapolis, Indiana
  71. Michigan City, Indiana
  72. Mishawaka, Indiana
  73. South Bend, Indiana
  74. West Des Moines, Iowa
  75. Lexington, Kentucky
  76. Louisville, Kentucky
  77. Paducah, Kentucky
  78. Russell Springs, Kentucky
  79. College Park, Maryland
  80. Pikesville, Maryland
  81. Brockton, Massachusetts
  82. Fall River, Massachusetts
  83. Waltham, Massachusetts
  84. Clarkston, Michigan
  85. Flint, Michigan
  86. Flint, Michigan
  87. Lansing, Michigan
  88. Rochester, Michigan
  89. Sterling, Michigan
  90. Edina, Minnesota
  91. Shakopee, Minnesota
  92. Biloxi, Mississippi
  93. Jackson, Mississippi
  94. Southhaven, Mississippi
  95. Florissant, Missouri
  96. Florissant, Missouri
  97. Jefferson City, Missouri
  98. Anaconda, Montana
  99. Omaha, Nebraska
  100. Omaha, Nebraska
  101. Atco, New Jersey
  102. Belvidere, New Jersey
  103. Elizabeth, New Jersey
  104. Hackensack, New Jersey
  105. Haddon Heights, New Jersey
  106. Linden, New Jersey
  107. Shrewsbury, New Jersey
  108. Trenton, New Jersey
  109. Glens Falls, New York
  110. Great Neck, New York
  111. Hartsdale, New York
  112. Long Beach, New York
  113. Mayville, New York
  114. North Syracuse, New York
  115. Valley Stream, New York
  116. Asheboro, North Carolina
  117. Asheboro, North Carolina
  118. Charlotte, North Carolina
  119. Hickory, North Carolina
  120. Jacksonville, North Carolina
  121. Winston-Salem, North Carolina
  122. Carlisle, Ohio
  123. Centerville, Ohio
  124. Cincinnati, Ohio
  125. Cincinnati, Ohio
  126. Delaware, Ohio
  127. Franklin, Ohio
  128. New Lexington, Ohio
  129. Perrysburg, Ohio
  130. Salem, Ohio
  131. Tiffin, Ohio
  132. Oklahoma City, Oklahoma
  133. Oklahoma City, Oklahoma
  134. Stillwater, Oklahoma
  135. Lake Oswego, Oregon
  136. Milwaukie, Oregon
  137. Allentown, Pennsylvania
  138. Aston, Pennsylvania
  139. Duncansville, Pennsylvania
  140. Harrisburg, Pennsylvania
  141. Philadelphia, Pennsylvania
  142. Philadelphia, Pennsylvania
  143. Wind Gap, Pennsylvania
  144. Anderson, South Carolina
  145. Charleston, South Carolina
  146. Charleston, South Carolina
  147. Greer, South Carolina
  148. Murrells Inlet, South Carolina
  149. North Charleston, South Carolina
  150. Orangeburg, South Carolina
  151. Watertown, South Dakota
  152. Chattanooga, Tennessee
  153. Hendersonville, Tennessee
  154. Corsicana, Texas
  155. Dallas, Texas
  156. El Paso, Texas
  157. Houston, Texas
  158. Houston, Texas
  159. Houston, Texas
  160. San Antonio, Texas
  161. Waco, Texas
  162. Waco, Texas
  163. Bountiful, Utah
  164. Norfolk, Virginia
  165. Edmonds, Washington
  166. Huntington, West Virginia
ALL GENDERS
21 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Conversion to Embeda With Rescue Trial
Official Title  ICMJE A Multi-Center, Primary Care-Based, Open-Label Study to Assess the Success of Converting Opioid-Experienced Patients, With Chronic, Moderate to Severe Pain, to EMBEDA Using a Standardized Conversion Guide, and to Identify Behaviors Related to Prescription Opioid Abuse, Misuse, and Diversion
Brief Summary The purpose of the research study is to find out if opioid dependent chronic pain patients who are judged by their physician to be eligible to change their current opioid medicine and to participate in this study can be successfully adjusted to a stable dose of EMBEDA (morphine sulfate and naltrexone hydrochloride). The study will also assess each patient's risk for prescription opioid abuse, misuse and diversion.
Detailed Description The decision to terminate the trial was based on a lack of study drug supply. The decision was not based on any safety concerns. The termination letter was sent on 11March2011.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Chronic Disease
  • Pain
Intervention  ICMJE Drug: morphine sulfate and naltrexone hydrochloride (EMBEDA)
Capsules in dose strengths ranging from 20 to 100 mg morphine sulfate with 0.8 to 4 mg of naltrexone hydrochloride taken either once or twice daily with a starting dose calculated using the total daily dose of the current opioid being converted from until a stable dose is achieved or six weeks which ever comes first.
Study Arms  ICMJE Experimental: morphine sulfate and naltrexone hydrochloride (EMBEDA)
Intervention: Drug: morphine sulfate and naltrexone hydrochloride (EMBEDA)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 30, 2012)
684
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2010)
1300
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be able to read, speak and understand English
  • Have chronic moderate to severe pain for at least 3 months
  • Require around the clock opioid medication for the relief of pain
  • Have been taking a daily opioid for at least 30 days prior to starting the study
  • Be able to be safely switched to a different pain medication
  • Be practicing acceptable birth control methods for female patients of childbearing potential
  • Be willing to participate in the study and able to comply with study procedures

Exclusion Criteria:

  • Be currently diagnosed with or participating in and/or seeking treatment for opioid and/or alcohol abuse
  • Be allergic or intolerant to morphine, morphine salts, naltrexone or other opioids
  • Be currently taking tramadol and/or extended release morphine products
  • Have respiratory depression
  • Have acute or severe bronchial asthma or severe chronic obstructive pulmonary disease
  • Have migraines as your main source of pain
  • Have any form of bowel obstruction
  • Be pregnant or breast feeding
  • Have had 2 or more surgeries for low back pain
  • Be planning a major surgery during the study
  • Be staying in a hospital or nursing home
  • Be planning to have steroid injections for your chronic pain during the study
  • Have a life expectancy of less than 2 months
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01179191
Other Study ID Numbers  ICMJE ALO-01-10-4003
B4541001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP